New York can set the standard for medical marijuana

By Steven Patierno, Commentary

Published 6:19 pm, Wednesday, July 8, 2015

While critics have claimed New York's medical marijuana regulations have set the bar too high for producers, it is those tough standards that will spark crucial innovation in cannabis-based medicines that will benefit patients in New York and throughout the country.

In fact, the state's law sets a new national standard for medical marijuana programs that will push cannabis up the drug development curve, leading to more effective medicines and safer, healthier delivery devices for patients suffering from debilitating illnesses.

This important shift begins with the law's requirement that each dose of medical marijuana administered in New York contain a consistent and precise amount of ingredients — within a plus-or-minus 5 percent range of accuracy. This is a pharmaceutical level of precision that does not exist in any other medical marijuana program throughout the country.

More Information

Dr. Steven Patierno is a professor of medicine and of pharmacology and cancer biology at the Duke University School of Medicine and deputy director of the Duke Cancer Institute. He is also chairman of the medical advisory board of PalliaTech, a New York-based medical cannabis company that is bidding for one of the state's five medical marijuana licenses.

To meet this high standard of precision, medical marijuana producers in New York will need to formulate products using what are called monocannabinoids, the cannabis plant's natural therapeutic chemicals in their isolated and pure forms. The use of monocannabinoids promises to usher in a new era of medical cannabis innovation, as producers will be able to develop medicines that are far more reliable, safe and effective than conventional medical marijuana alternatives currently offered across the U.S.

This dosing requirement is a particularly crucial standard in light of a recent study documenting the inconsistency of ingredients and mislabeling of potencies in many medical marijuana products sold in other states. These inconsistencies can have significant adverse effects for patients, and the New York solution may explain much of the angst surrounding the program, as joints and brownies will not be considered medicines.

New York is also the first state to require metered dosing — measuring active ingredients in consistent milligram amounts to give physicians a vital tool for treating patients with medical cannabis as they do using traditional pharmaceuticals. As a result, many more doctors will be able to recommend and manage cannabis therapies for patients desperately in need of relief from the pain and discomfort of serious debilitating diseases and conditions.

While it is true that few participants in the cannabis industry are capable of producing monocannabinoid-based medicines to pharmaceutical standards — and fewer still that can do so in time to meet the January 2016 deadline to launch the program — history shows us that the industry can evolve to meet the high standards.

But just as producers of aspirin advanced the most successful palliative medicine from white willow bark to extracted formulations to a synthesized drug, a new generation of producers in New York will move beyond simply cultivating a therapeutically beneficial plant to manufacturing high-quality modern medicines that are safer and more effective for patients.

By manufacturing individually dosed medicines, New York will also enable greater supply chain controls and lower law enforcement risk. Any medicine distributed in bar-coded, pharma-grade packaging is much harder to divert for illegal uses. The same cannot be said in other states, where medical cannabis shipped from production facilities and sold to patients in bulk plant form is not readily distinguishable from the street drug.

As a palliative drug that can ease the pain and suffering caused by a wide range of illnesses from cancer to epilepsy to multiple sclerosis, cannabis has vast therapeutic potential. The challenge of unlocking that potential to benefit thousands of patients is greatly enhanced, not limited, by the monocannabinoid revolution that we are witnessing in New York.